Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06075550
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-04-21
Brief Title:
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers With Obturation Techniques
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Assessment of Postoperative Pain of Two Bioceramic Root Canal Sealers After Different Obturation Techniques A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
60 patients were divided into 2 groups 30 patient in each group
Group I Obturation with TotalFill BC Sealer using the single cone technique
Group II Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique
Every participant will be given a Visual Analog Scale VAS to record the intensity of postoperative pain at 6 hr 24 hr 48 hr 72 hr and 1week after treatment The patients will return their Visual Analog Scale VAS after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group
Group I Obturation with TotalFill BC Sealer using the single cone technique
Group II Obturation with TotalFill BC Sealer HiFlow using the warm vertical compaction technique
Every participant will be given a Visual Analog Scale VAS to record the intensity of postoperative pain at 6 hr 24 hr 48 hr 72 hr and 1week after treatment The patients will return their Visual Analog Scale VAS after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group
Detailed Description:
Endodontic treatment will be performed in a single visit
Root canal preparation
After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab
All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant
Cleaning and shaping of the canal will be performed using rotary ProTaper Next files Dentsply Maillefer connected to an endodontic motor according to the manufacturers instructions and recommendations
Irrigation with sodium hypochlorite will be always performed during instrumentation
After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points
Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups
Root canal obturation
This study will be a double blind randomized study
Group I Using TotalFill BC Sealer the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer A ProTaper Next gutta percha cone Dentsply Maillefer of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser
Group II TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done The depth of the heated plugger will be 5 mm less than the WL followed by back filling
After obturation the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling
A postoperative radiograph will be taken
Assessment of postoperative pain
Every participant will be given a Visual Analog Scale VAS to record the intensity of postoperative pain at 6 hr 24 hr 48 hr 72 hr and 1week after treatment The patients will return their Visual Analog Scale VAS after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group
Root canal preparation
After anesthesia a rubber dam will be placed then disinfection of the working field will be done using sodium hypochlorite swab
All caries will be removed then an endodontic access cavity will be established using high speed carbide burs under coolant
Cleaning and shaping of the canal will be performed using rotary ProTaper Next files Dentsply Maillefer connected to an endodontic motor according to the manufacturers instructions and recommendations
Irrigation with sodium hypochlorite will be always performed during instrumentation
After instrumentation a final flush with sodium hypochlorite followed by distilled water will be performed and the canals will be dried using sterile paper points
Master cone radiograph will be taken for confirmation and obturation will be done according to the mentioned groups
Root canal obturation
This study will be a double blind randomized study
Group I Using TotalFill BC Sealer the tip of the syringe will be inserted into the canal and the sealer will be dispensed into the root canal as recommended by the manufacturer A ProTaper Next gutta percha cone Dentsply Maillefer of the same size of the prepared canal will be used for single cone obturation technique and the excess gutta percha will be removed by a heated condenser
Group II TotalFill BC Sealer HiFlow will be inserted into the canal as in Group I and the master gutta percha cone will be placed and warm vertical compaction technique will be done The depth of the heated plugger will be 5 mm less than the WL followed by back filling
After obturation the access cavity will be cleaned and a sterile cotton pellet is placed and the cavity will be sealed with temporary filling
A postoperative radiograph will be taken
Assessment of postoperative pain
Every participant will be given a Visual Analog Scale VAS to record the intensity of postoperative pain at 6 hr 24 hr 48 hr 72 hr and 1week after treatment The patients will return their Visual Analog Scale VAS after 1 week and the recorded pain data will be collected and statistically analyzed regarding each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None